Evaluation of the Effectiveness of a Quality Improvement Intervention

February 18, 2020 updated by: Christiane Horwood, University of KwaZulu

Evaluation of the Effectiveness of a Quality Improvement Intervention to Support Integration of Maternal, and Child and HIV Care in Primary Health Care Facilities in South Africa

This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.

Study Overview

Detailed Description

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.

Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.

Study Type

Interventional

Enrollment (Actual)

1438

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Exclusion Criteria:

Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Provision of comprehensive care including the following:

Baby:

Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive -

  • Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks
  • Nevirapine for the baby for six weeks

Mother:

Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs)

HIV Care:

  • HIV positive mothers - provide ART for the mother and adherence support
  • HIV negative mothers- HIV test every three months while breastfeeding
Quality improvement intervention comprising of regular improvement meetings based at clinics.
Active Comparator: Control
Routine maternal and child care service delivery
Quality improvement intervention comprising of regular improvement meetings based at clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Maternal and Child Care
Time Frame: 3 months
Proportion of mother-baby pairs who received comprehensive care
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Child Care
Time Frame: 3 months
Proportion of babies who receive growth monitoring services
3 months
Quality of Maternal Care
Time Frame: 3 months
Proportion of mothers who receive feeding advice
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2016

Primary Completion (Actual)

February 5, 2017

Study Completion (Actual)

January 16, 2019

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will not be shared

IPD Sharing Time Frame

Anytime

IPD Sharing Access Criteria

We are more than happy to share our study protocol, statistical analysis plan or informed consent with anyone who is interested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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